Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)— 510(k) K261083
Substantially EquivalentCooperSurgical, Inc.
FDA 510(k) clearance K261083 for Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK), Substantially Equivalent on 2026-08-19. Applicant: CooperSurgical, Inc.. Device class: 2.
Summary
CooperSurgical's submission covers three Wallace items: an Aspiration Pump (WAPV1), a Pump Filter Connector (WFC), and a Vacuum Connection Kit (WVCK). They're filed under product code MQG, assisted reproduction accessories.
Class II, 21 CFR 884.6120. Obstetrics/Gynecology is both the classification panel and the review panel, and it was a Traditional 510(k).
CooperSurgical filed from Trumbull, Connecticut. FDA found it substantially equivalent 140 calendar days after receipt (April 1 to August 19, 2026).
Clearance details
- Applicant
- CooperSurgical, Inc.
- Product code
- Product code MQG
- Device class
- Class 2
- Regulation
- 21 CFR 884.6120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trumbull, CT, US
Recent devices under product code MQG
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